Kelyniam Global, Inc. Receives FDA Clearance for Innovative Fusion™ BCP-PEEK Implant

Core Viewpoint - Kelyniam Global, Inc. has received FDA 510(k) clearance for its Fusion Cranial and Craniofacial Implants, marking a significant advancement in implant technology and the first approval of its kind in 8 years [1][2]. Company Overview - Kelyniam Global, Inc. specializes in custom cranial and craniofacial implants, utilizing biocompatible materials to provide patient-specific solutions with rapid turnaround times [4]. Product Details - The Fusion BCP-PEEK implants are made from a unique combination of Biphasic Calcium Phosphate (BCP) reinforced with Polyether Ether Ketone (PEEK), designed to encourage bone integration and provide exceptional durability [1][3]. - These implants are tailored for specific neurosurgery needs, addressing traumatic injuries, tumor resections, and congenital anomalies, and can be designed and shipped within 24-48 hours [3]. Market Impact - The FDA clearance represents a milestone in the cranial and craniofacial implant market, as it is the first new implant introduced in 8 years, highlighting Kelyniam's innovative capabilities [2][3].